ARCA biopharma has filed an investigational new drug (IND) application with the US Food and Drug Administration (FDA) to conduct a Phase IIb/III clinical trial of AB201 to treat hospitalised Covid-19 patients.
The submission has been done under the Coronavirus Treatment Acceleration Programme (CTAP), a special emergency programme by the FDA for potential Covid-19 therapies.
Awaiting response from the FDA, ARCA expects to commence the Phase IIb portion of the sequential Phase IIb/III study of AB201 by the fourth quarter of the year.
ARCA biopharma president and CEO Michael Bristow said: “This IND submission is a key milestone in the clinical development of AB201.
“With what we believe to be a strong scientific rationale, safety data from prior human clinical trials in over 700 patients, and a well-defined regulatory pathway, we believe AB201 has potential as a therapeutic treatment for Covid-19, as well as other RNA virus-associated diseases.”
AB201, a small recombinant protein, is in the development stage to potentially treat RNA virus-associated diseases, with an initial focus on Covid-19.
It is a potent, selective inhibitor of tissue factor (TF), which is known to have a major role in the inflammatory response to viral infections and in the viral dissemination process.
AB210 also exhibits a mechanism that combines anti-coagulant, immuno-modulation, and anti-viral properties. This mechanism may help address pathologies caused by viral infections from different aspects.
The drug candidate was subjected to Phase I and II trials in more than 700 patients, including studies to prevent venous and arterial thrombosis. It was observed to inhibit the TF pathway and was well tolerated at therapeutic doses.
Recent research and former studies in non-human primates (NHPs) with Ebola or Marburg filoviruses showed that AB201 has potential for antiviral and anti-inflammatory activity, along with anticoagulant effects.
ARCA believes that these findings form a strong rationale for testing AB201 as a treatment for RNA virus-associated diseases, including Covid-19.
In February last year, ARCA announced plans to assess Gencaro as a genetically-targeted therapy in a pivotal Phase III trial for atrial fibrillation (AF) in patients with a certain type of heart failure (HF).